Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Borrelia burgdorferi total antibody IVD, kit, immunoblot FDA UDI
- Device Name
- FITC Mounting Medium (pH 7.5), 3.0 mL FDA UDI
- Model / Reference
- 90-1610 FDA UDI
- Description
- FITC Mounting Medium (pH 7.5), 3.0 mL FDA UDI
Identifiers
- Catalog Number
- 90-1610 FDA UDI
- Primary DI / UDI-DI
- 05391516747943 FDA UDI
- FDA Product Code
- LEB FDA UDIMVJ FDA UDINUK FDA UDIMIV FDA UDINUL FDA UDILOO FDA UDILSR FDA UDI
- GMDN Term
- Borrelia burgdorferi total antibody IVD, kit, immunoblot FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI866.5660 FDA UDI866.3870 FDA UDI866.3830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Borrelia burgdorferi total antibody IVD, kit, immunoblotGlomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassaySkeletal muscle antibody IVD, kit, fluorescent immunoassayTrypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
Trinity Biotech by Mardx Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay.
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI 72f5744e-b88d-42d2-bbae-c65f2b1f9e06 36 fields · synced Jun 7, 2026